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太赫兹光谱在制药科学中的应用。

Applications of terahertz spectroscopy to pharmaceutical sciences.

作者信息

Taday Philip F

机构信息

TeraView Limited, 302/304 Cambridge Science Park, Milton Road, Cambridge CB4 0WG, UK.

出版信息

Philos Trans A Math Phys Eng Sci. 2004 Feb 15;362(1815):351-63; discussion 363-4. doi: 10.1098/rsta.2003.1321.

Abstract

The application of terahertz pulsed spectroscopy within the US Food and Drug Administration's (FDA's) recent process analytical technology (PAT) initiative is considered. As a case study the potency levels in paracetamol (4-acetamidophenol) and aspirin (acetylsalicylic acid) test tablets have been recovered from the terahertz absorption spectra using a multivariate partial-least-squares (PLS) calibration model. Root-mean-square errors of cross-validation (RMSECVs) of 2.85% and 3.90% were obtained for paracetamol and aspirin, respectively. Information about other excipients can also be obtained; for example, using the strong lactose absorption lines in the tablets, RMSECVs of 3.65% and 4.30% could be recovered from the paracetamol and aspirin samples, respectively. As active ingredients may also change their solid-state form during formulation processing or storage and as this can adversely affect the final dosage performance, monitoring of pharmaceutical ingredients is essential for a 'right-first-time' philosophy within the industry. Terahertz pulse spectroscopy is a high-throughput technique with many areas of potential exploitation in the pharmaceutical industry; these issues are discussed in this paper.

摘要

本文考虑了太赫兹脉冲光谱在美国食品药品监督管理局(FDA)近期的过程分析技术(PAT)计划中的应用。作为一个案例研究,使用多元偏最小二乘(PLS)校准模型从太赫兹吸收光谱中恢复了对乙酰氨基酚(4-乙酰氨基酚)和阿司匹林(乙酰水杨酸)测试片剂中的效价水平。对乙酰氨基酚和阿司匹林的交叉验证均方根误差(RMSECV)分别为2.85%和3.90%。还可以获得有关其他辅料的信息;例如,利用片剂中乳糖的强吸收线,对乙酰氨基酚和阿司匹林样品的RMSECV分别为3.65%和4.30%。由于活性成分在制剂加工或储存过程中也可能改变其固态形式,并且这可能对最终剂型性能产生不利影响,因此对药物成分的监测对于制药行业的“一次成功”理念至关重要。太赫兹脉冲光谱是一种高通量技术,在制药行业有许多潜在的应用领域;本文将讨论这些问题。

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